Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: GDUFA inspections, FDA’s inspection workforce, device warning letters, 3D drug printers, CMC/GMP guidance agenda

This article was originally published in The Gold Sheet

Executive Summary

FDA discusses GDUFA II inspectional transparency issues with industry; FDA plans global workforce; device warning letter rate fell; why FDA needs a 3D drug printer; and CMC trumps GMP in FDA agenda.

You may also be interested in...



GDUFA II: Inspection Information Takes Center Stage

Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.

Pulling In 10 Different Directions – The Challenge Of Harmonizing Asia’s VMS Market

A lack of regulatory harmonization for dietary supplements in Asia is a big challenge facing companies operating in the region, according to experts from the Asia Regulatory Professionals Association. The ARPA is looking to start a conversation on the issue which the association hopes will lead to regulatory change.

China CSCO Hails Rising Liver Cancer Innovation Ready To Take On World

The Chinese Society of Clinical Oncology (CSCO) annual meeting, against the background of the global pandemic, has one clear message that local researchers and players are pressing ahead to take a leadership role in cutting-edge cancer research globally.

Topics

UsernamePublicRestriction

Register

PS142351

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel